BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER NON-LOCKING SCREW

    MDR report key: 6715193 · Received July 14, 2017

    Report

    Report Number
    0001825034-2017-04977
    Event Type
    Injury
    Date Received
    July 14, 2017
    Date of Event
    October 4, 2016
    Report Date
    February 2, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK132239
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING REPORT IS SUBMITTED TO RELAY ADDITIONAL INFORMATION THE REPORTED EVENT IS CONFIRMED WITH REVIEW OF THE PROVIDED SURGICAL NOTES AS WELL AS THE RETURNED PRODUCTS. VISUAL EXAMINATION SHOWED GOUGES, NICKS AND EXCESSIVE WEAR. THIS VISUAL ABRASION CONFIRMS THE MIGRATION OF THE GLENOSPHERE, WHICH IS EVIDENCE OF DISASSOCIATION. AMONG THE RETURNED ITEMS WAS A SCREW NOT COMPATIBLE WITH THE OTHER IMPLANTS; WHILE THIS COULD HAVE BEEN A CONTRIBUTING FACTOR IT CANNOT BE CONFIRMED WHETHER THIS SCREW WAS USED IN THE PRIMARY PROCEDURE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCTS-BASEPLATE CATALOG#:010000589 LOT#:184750, LOCKING SCREW. CATALOG#:180550 LOT#:808790, SCREW. CATALOG#:180560 LOT#:119660, BEARING. CATALOG#:XL-115363 LOT#:169800, SCREW. CATALOG#:115396 LOT#:399510, STEM. CATALOG#:113617 LOT#:909350, GLENOSPHERE. CATALOG#:115316 LOT#:321870, TRAY. CATALOG#:115370 LOT:910010, DRILL. CATALOG#:405883 LOT#:562300, PIN. CATALOG#:405800 LOT#:193340. THE DEVICE HAS BEEN RECEIVED BY ZIMMER BIOMET (B)(4) FOR EVALUATION. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:0001825034-2017-02775, 0001825034-2017-04973, 0001825034-2017-04976, 0001825034-2017-04978, 0001825034-2017-04979.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT UNDERWENT A RIGHT TOTAL SHOULDER ARTHROPLASTY REVISION APPROXIMATELY FOUR MONTHS POST-IMPLANTATION DUE TO DISASSOCIATION OF THE TAPER FROM THE BASEPLATE. ADDITIONAL INFORMATION RECEIVED IN REVISION OPERATIVE NOTES, ALSO NOTES THE PATIENT WAS EXPERIENCING PAIN AND A GRINDING SENSATION PRIOR TO REVISION. DURING THE REVISION, SIGNIFICANT LINER EROSION WAS NOTED, AND THE BASEPLATE WAS FOUND TO BE LOOSE, WITH MARKED GLENOID BONE DEFICIENCY. ALL COMPONENTS, EXCEPT THE HUMERAL STEM, WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496509 COMPREHENSIVE REVERSE SHOULDER NON-LOCKING SCREW PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 224880

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R